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Methods for identification of pregnancy failure

a technology for failure and detection method, applied in the field of pregnancy failure, can solve the problems of inconclusive pregnancy, difficult to distinguish between intrauterine and extrauterine pregnancies (iup and eup, respectively), vaginal bleeding and intrauterine cramping, etc., and achieve the effect of safe, non-invasive and effective methods

Active Publication Date: 2019-12-17
MOR AMIR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]The invention provides an effective, safe and non-invasive method for same-day detection of pregnancy failure, which may be used in early-stage pregnancy.

Problems solved by technology

Common symptoms of pregnancy failure include vaginal bleeding and intrauterine cramping.
Sonographic findings in early pregnancy may be inconclusive, and differentiating between intrauterine and extra-uterine pregnancies (IUP and EUP, respectively) is challenging.
Moreover, serial beta Human Chorionic Gonadotropin (β-HCG) measurements over time are oftentimes needed in order to differentiate between a normal and a failing pregnancy and therefore, may not be useful for same-day diagnosis.

Method used

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  • Methods for identification of pregnancy failure
  • Methods for identification of pregnancy failure
  • Methods for identification of pregnancy failure

Examples

Experimental program
Comparison scheme
Effect test

example 1

ntration as an Indicator of Pregnancy Failure

Materials and Methods:

Subjects

[0049]A total of 78 pregnant women in their first or second trimesters were recruited at the Maimonides Medical Center Labor and Delivery Department, Brooklyn, N.Y.

[0050]Written consent was obtained from all study participants prior to participation.

[0051]Four subject groups were evaluated:[0052](1) Women with incomplete / missed abortion experiencing vaginal bleeding as identified according to the diagnostic criteria for a nonviable intrauterine pregnancy (IUP) provided by Doubilet et al.3, which is incorporated by reference as if fully set forth herein;[0053](2) Women with threatened abortion i.e. not passing fetal or embryonic tissue, experiencing vaginal bleeding, with a confirmed IUP and visible fetal or embryonic heartbeat;[0054](3) Women experiencing vaginal bleeding during cerclage placement, with visible fetal or embryonic heartbeat before and after the cercelage procedure (negative control group for p...

example 2

ntration as an Indicator of Pregnancy Failure

[0084]An additional example of an element of fetal or embryonic origin for use in the methods of the present invention is fetal or embryonic DNA / RNA. The presence of fetal or embryonic genetic material above a threshold level of about 2% of the total DNA / RNA sample obtained can confirm, for example, pregnancy failure. Moreover, laboratory or bedside tests for the sequence of these molecules can provide information about the etiology of the pregnancy failure (e.g., fetal or embryonic chromosomal abnormalities) without or prior to obtaining fetal or embryonic tissue.

[0085]For example, trisomy 13 and 18 are not rare and can result in early pregnancy loss. The sample of vaginal bleeding for these genetic abnormalities or other abnormalities such as mutations, deletions, duplications, and oligonucleotide repeats can provide the etiology of the failing pregnancy.

[0086]DNA / RNA levels may be detected by any method known in the art. As a non-limit...

example 3

ryonal Hemoglobin Concentration as an Indicator of Pregnancy Failure

[0092]An additional example of an element of fetal or embryonic origin for use in the methods of the present invention is fetal or embryonic hemoglobin (HbF). The presence of fetal or embryonic hemoglobin above a threshold level detected in the maternal serum can confirm pregnancy failure. Alternatively, since oftentimes HbF is not detected at all in the maternal serum or is present in relatively low levels, a detectable IMF in the vaginal blood above a determined threshold can confirm pregnancy failure, such that the threshold level is zero or a relatively low number / percentage. In general, HbF in the newborn is 60 to 80% of the total hemoglobin whereas it is only 0 to 2% in the maternal serum.

[0093]Subjects were recruited, evaluated, and an IUP confirmed as described for Example 1 above.

[0094]Fetal or embryonic hemoglobin concentration was measured using an immunoassay using antibodies reacting specifically with h...

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Abstract

Provided is a method for identifying pregnancy failure in a subject, the method comprising determining a concentration of at least one element of fetal or embryonic origin in the vaginal fluid of the subject; and comparing the concentration of the at least one element of fetal or embryonic origin to a reference value, wherein when the concentration of the at least one element of fetal or embryonic origin in the vaginal fluid is higher than the reference value, pregnancy failure is indicated.

Description

FIELD OF THE INVENTION[0001]The invention relates to the field of pregnancy failure, and more particularly, to a method for identification of pregnancy failure comprising comparing a concentration of at least one element of fetal or embryonic origin in the vaginal fluid of a subject to a reference concentration of the same element of fetal or embryonic origin.BACKGROUND OF THE INVENTION[0002]Pregnancy failure is common, occurring in about 12 to 15% of all clinically recognized pregnancies, and up to 22% of all pregnancies in the United States. Common risk factors include chromosomal abnormalities.[0003]Common symptoms of pregnancy failure include vaginal bleeding and intrauterine cramping. However, such symptoms may also occur during normal gestation, especially during the first trimester.[0004]Sonographic findings in early pregnancy may be inconclusive, and differentiating between intrauterine and extra-uterine pregnancies (IUP and EUP, respectively) is challenging.[0005]Moreover, ...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): G01N33/68G01N33/53A61B5/00
CPCG01N33/689A61B5/4343C12Q2600/158G01N2800/368C12Q1/6883
Inventor MOR, AMIR
Owner MOR AMIR